The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0686-2017·Announced 2017-05-03

Isomeric Pharmacy Recalls Testosterone Injection Vials Due to Sterility Concerns

Isomeric Pharmacy Solution, LLC is recalling 2,156 vials of Testosterone Cypionate and Propionate injection due to production processes that cannot assure sterility.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of infection or serious injury, meeting the criteria for a Severe rating.

Plain-English summary

Isomeric Pharmacy Solution, LLC is recalling 2,156 vials of Testosterone Cypionate 200 mg/mL, Testosterone Propionate 20 mg/mL, 30 mL Multi-Dose Vial For Injection. The recall was initiated because of concerns with production processes that cannot assure the sterility of products intended to be sterile.

The affected product is distributed nationwide in the USA and Puerto Rico. Specific lot numbers and expiration dates are listed in the recall notice, including lots 09018 through 12021 with expiration dates ranging from April 2017 to July 2017.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions. The FDA classifies this recall as Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Testosterone Cypionate 200 mg/mL, Testosterone Propionate 20 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1200, barcode 3 70285 12003 9.
Manufacturer
Isomeric Pharmacy Solution, LLC
Category
Drug — Injectable Steroids
Hazard
Affected units
2,156

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot #s: 09018
  • Exp 04/17/17
  • 09023
  • Exp 04/22/17
  • 09024
  • Exp 04/23/17
  • 09027
  • Exp 04/25/17
  • 09031
  • Exp 04/30/17
  • 10005
  • Exp 05/06/17
  • 10010
  • Exp 05/09/17
  • 11022
  • Exp 06/10/17
  • 11038
  • Exp 06/18/17
  • 11044
  • Exp 07/04/17

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 7 recalled by Isomeric Pharmacy Solution, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

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